FDA.reportPublic FDA data

Relief Pain Relieving Cream

Product NDC
58559-001
11-digit product format
585590001
Labeler code
58559
Product ID
58559-001_48617c36-0ba4-cc34-e063-6394a90a0f20
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
CREAM
Route
TOPICAL
Labeler
Corganics, LP
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2004-05-22
Substance
MENTHOL
Active strength
2.5 g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Relief Pain Relieving Cream
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL2.5 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A
Rxcui1291226

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58559-001-012026-01-15C16284748780-19d75b9d0-39f4-f424-e053-dadaa90a57ceDRUG FACTS
58559-001-022026-01-15C16284748780-19d75b9d0-39f4-f424-e053-dadaa90a57ceDRUG FACTS
58559-001-032026-01-15C16284748780-19d75b9d0-39f4-f424-e053-dadaa90a57ceDRUG FACTS
58559-001-042026-01-15C16284748780-19d75b9d0-39f4-f424-e053-dadaa90a57ceDRUG FACTS
58559-001-052026-01-15C16284748780-19d75b9d0-39f4-f424-e053-dadaa90a57ceDRUG FACTS
58559-001-012020-01-31C16284748780-19d75b9d0-39f4-f424-e053-dadaa90a57ceDRUG FACTS
58559-001-022020-01-31C16284748780-19d75b9d0-39f4-f424-e053-dadaa90a57ceDRUG FACTS
58559-001-032020-01-31C16284748780-19d75b9d0-39f4-f424-e053-dadaa90a57ceDRUG FACTS
58559-001-042020-01-31C16284748780-19d75b9d0-39f4-f424-e053-dadaa90a57ceDRUG FACTS
58559-001-052020-01-31C16284748780-19d75b9d0-39f4-f424-e053-dadaa90a57ceDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58559-001-01Relief Pain Relieving Cream5 g in 1 BLISTER PACKCREAM52
58559-001-02Relief Pain Relieving Cream82 g in 1 BOTTLE, WITH APPLICATORCREAM822
58559-001-03Relief Pain Relieving Cream115 g in 1 TUBECREAM1152
58559-001-04Relief Pain Relieving Cream450 g in 1 BOTTLE, PUMPCREAM4502
58559-001-05Relief Pain Relieving Cream3600 g in 1 BOTTLE, PUMPCREAM36002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3ARELIEF PAIN RELIEVING CREAM (MENTHOL) CREAM [CORGANICS, LP]1
MENTHOLACTIVE MOIETYL7T10EIP3ARELIEF PAIN RELIEVING CREAM (MENTHOL) CREAM [CORGANICS, LP]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0RELIEF PAIN RELIEVING CREAM (MENTHOL) CREAM [CORGANICS, LP]1
ALOEINACTIVE INGREDIENTV5VD430YW9RELIEF PAIN RELIEVING CREAM (MENTHOL) CREAM [CORGANICS, LP]1
ARGININEINACTIVE INGREDIENT94ZLA3W45FRELIEF PAIN RELIEVING CREAM (MENTHOL) CREAM [CORGANICS, LP]1
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDEINACTIVE INGREDIENTFJ1H6M2JG9RELIEF PAIN RELIEVING CREAM (MENTHOL) CREAM [CORGANICS, LP]1
CARBOMER COPOLYMER TYPE AINACTIVE INGREDIENT71DD5V995LRELIEF PAIN RELIEVING CREAM (MENTHOL) CREAM [CORGANICS, LP]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SRELIEF PAIN RELIEVING CREAM (MENTHOL) CREAM [CORGANICS, LP]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNRELIEF PAIN RELIEVING CREAM (MENTHOL) CREAM [CORGANICS, LP]1
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4RELIEF PAIN RELIEVING CREAM (MENTHOL) CREAM [CORGANICS, LP]1
DIMETHYL SULFONEINACTIVE INGREDIENT9H4PO4Z4FTRELIEF PAIN RELIEVING CREAM (MENTHOL) CREAM [CORGANICS, LP]1
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI662RELIEF PAIN RELIEVING CREAM (MENTHOL) CREAM [CORGANICS, LP]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXRELIEF PAIN RELIEVING CREAM (MENTHOL) CREAM [CORGANICS, LP]1
HYDROGENATED SOYBEAN LECITHININACTIVE INGREDIENTH1109Z9J4NRELIEF PAIN RELIEVING CREAM (MENTHOL) CREAM [CORGANICS, LP]1
LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H8RELIEF PAIN RELIEVING CREAM (MENTHOL) CREAM [CORGANICS, LP]1
ORANGE OILINACTIVE INGREDIENTAKN3KSD11BRELIEF PAIN RELIEVING CREAM (MENTHOL) CREAM [CORGANICS, LP]1
PALMAROSA OILINACTIVE INGREDIENT0J3G3O53STRELIEF PAIN RELIEVING CREAM (MENTHOL) CREAM [CORGANICS, LP]1
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JHRELIEF PAIN RELIEVING CREAM (MENTHOL) CREAM [CORGANICS, LP]1
POLYOXYL 20 CETOSTEARYL ETHERINACTIVE INGREDIENTYRC528SWUYRELIEF PAIN RELIEVING CREAM (MENTHOL) CREAM [CORGANICS, LP]1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P8RELIEF PAIN RELIEVING CREAM (MENTHOL) CREAM [CORGANICS, LP]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKRELIEF PAIN RELIEVING CREAM (MENTHOL) CREAM [CORGANICS, LP]1
WATERINACTIVE INGREDIENT059QF0KO0RRELIEF PAIN RELIEVING CREAM (MENTHOL) CREAM [CORGANICS, LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58559-001RELIEF PAIN RELIEVING CREAM (MENTHOL) CREAM [CORGANICS, LP]1Current NDC, Legacy NDC, 5 package rows20141119_85814fff-35f8-447f-b669-87eaf55e9859.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1291226menthol 2.5 % Topical CreamPSN85814fff-35f8-447f-b669-87eaf55e98592
1291226menthol 25 MG/ML Topical CreamSCD85814fff-35f8-447f-b669-87eaf55e98592
1291226menthol 2.5 % Topical CreamSY85814fff-35f8-447f-b669-87eaf55e98592

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58559-001-01585590001015 g in 1 BLISTER PACK (58559-001-01) 5 g2004-05-22NoNoHistorical
58559-001-025855900010282 g in 1 BOTTLE, WITH APPLICATOR (58559-001-02) 82 g2004-05-22NoNoHistorical
58559-001-0358559000103115 g in 1 TUBE (58559-001-03) 115 g2004-05-22NoNoHistorical
58559-001-0458559000104450 g in 1 BOTTLE, PUMP (58559-001-04) 450 g2004-05-22NoNoHistorical
58559-001-05585590001053600 g in 1 BOTTLE, PUMP (58559-001-05) 3600 g2004-05-22NoNoHistorical